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510(k) Data Aggregation
(257 days)
The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos.
The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) are intended for use in closed vitrification procedures to contain and maintain human oocytes (MI), 4-8 cell embryos, and blastocyst stage embryos, and they are intended for use in professional healthcare facilities. The subject devices are for single use, disposable and supplied sterile.
The Minvitro® Vitrification Straws (MVT-VSN series: MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) are all composed of a cap with a balancing head, a handle, a carrier sheet with a fine tip at the end. The oocytes or embryos are loaded on the carrier sheet, and in which, the fine tip of carrier sheet is flat with a triangular-shaped area for oocyte/embryo loading. The subject devices are sterilized using ethylene oxide (EO) to a sterilization assurance level of 106, are singleuse, and have a 2-year shelf-life.
The subject devices are available in five colors: MVT-VSNR. MVT-VSNY. MVT-VSNB. MVT-VSNG, and MVT-VSNP corresponding to Red, Yellow, Blue, Green, and Purple, respectively, all identical in size.
The Minvitro® Vitrification Straw (K241454) is a cryopreservation storage device. It underwent non-clinical performance testing to demonstrate its substantial equivalence to the predicate device, Cryotop® US-flash (K181469).
Here's an overview of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criterion | Reported Device Performance (Minvitro® Vitrification Straw) |
|---|---|---|
| Sterilization | SAL of 10⁻⁶ (EO process) | Validated in accordance with ISO 11135:2014, ISO 11607-1-2006/Amd 1-2014, ISO 11607-2-2006/Amd 1-2014, ISO 11737-1:2018, ISO 11737-2:2009, ISO 11138-2:2017, ISO 10993-7:2008/Cor 1-2009. |
| Endotoxin | ≤ 0.5 EU/device | < 0.5 EU/device (using Gel-Clot Limulus Amoebocyte Lysate (LAL) method) |
| Cooling Rate (closed cap) | -3000 °C/min (similar to predicate) | Performed within specifications (comparative analysis against predicate K181469) |
| Warming Rate (closed cap) | 40000 °C/min (subject's specific) | Performed within specifications (comparative analysis against predicate K181469) |
| Mouse Embryo Assay (MEA) | ≥ 80% embryos developed to expanded blastocyst at 96 hours (1-Cell System) | Met acceptance criterion (testing conducted in accordance with 2021 FDA guidance) |
| Package Integrity | Maintain integrity after testing | Passed tests as per O F1886/F1886M-16, ASTM F88/F88M-15, ASTM F1929-15. |
| Mechanical Performance | Maintain performance | Passed dimensional testing, examination following cryostorage, seal integrity and leakage assessment following cryostorage, capping force and torque testing, uncapping force and torque testing. |
| Simulated Transportation & Conditioning | Maintain performance after simulation | Performed after accelerated aging per ASTM D4169-22 and environmental conditioning per ASTM D4332-22. Device maintained performance. |
| Shelf Life | 2 years | Demonstrated after 2-years of accelerated aging per ASTM F1980-21 and simulated transportation/conditioning. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific numerical sample sizes for each test in the test set. However, it implicitly indicates that sufficient samples were used to perform each test (e.g., "devices" for endotoxin, "embryos" for MEA).
The information provided suggests the data provenance is from non-clinical laboratory testing. No specific country of origin for the data is mentioned, but the manufacturer is based in Guangzhou, China. The nature of these tests is prospective as they are conducted as part of the submission process to demonstrate device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish ground truth for the non-clinical tests. These tests are typically conducted according to established international standards (e.g., ISO, ASTM, USP) and FDA guidance documents, which inherently define the "ground truth" through their methodologies and acceptance criteria. For the Mouse Embryo Assay (MEA), the "ground truth" (i.e., ≥80% blastocyst development) is a predefined industry standard for device suitability in assisted reproduction technology.
4. Adjudication method for the test set
Not applicable. The tests described are objective, quantitative laboratory tests with predefined acceptance criteria based on standards. There is no mention of human adjudication for these non-clinical performance studies.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device described is a cryopreservation storage device, not an AI-powered diagnostic or imaging device. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical device (vitrification straw), not an algorithm or software. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used
For the non-clinical performance tests, the "ground truth" is primarily based on:
- Industry and regulatory standards/guidance: Standards like ISO 11135, ASTM D4169, USP <85>, and FDA guidance for MEA define the acceptable parameters and outcomes for device performance.
- Predicate device's specifications: For tests like cooling/warming rates, the predicate device's performance characteristics served as a benchmark for comparison.
- Pre-defined biological endpoints: In the case of the Mouse Embryo Assay, the development of embryos to the blastocyst stage at a certain percentage defines the biological "ground truth" for toxicity and suitability.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set" in the context of algorithm development. The tests described are for a physical medical device.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
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